(a) Field of the Invention
The present invention relates to medical devices and a therapeutic method for the treatment and the prevention of physical troubles associated with a statural disequilibrium.
(b) Description of Prior Art
A major part of the chronic pains of the back or of the neck are caused by spine disequilibrium. This disequilibrium is clinically associated with imbalances or rotations of the pelvic and pectoral girdles.
It has been documented that less than 10% of the population has perfectly balanced pelvic and pectoral girdles, i.e., an equilibrated spine. Those individuals almost never experience back or neck chronic pain in their life span, and are rarely prone to arthrosis. Constitutive or acquired imbalances occur in the remaining 90% of the population, in whom spine curvatures and intervertebral angles are non-physiologic, leading to pain, sequentially at the muscular, articular and ultimately the bone level.
Spine disequilibrium may also be responsible for various disorders, including muscular and articular pains, vertigos, lumbagos, arthrosis. The link between these disorders and the spine was established based on observations that correction of the pelvic and pectoral girdles imbalances resulted in improvements of the symptoms.
Various therapeutic approaches have been developed to restore the spine equilibrium, and thus alleviate chronic pains in patients. Most of these approaches involve the design of pedal devices, mainly soles, since the feet are the points of normal support of the body in human. In fact, it has been proven that the feet are the origin of ascending neural proprioceptive chains that control the tonus of the statural muscular system, of which the spine muscles are one component. Adequate stimulations of particular reflex zones located on the sole of the feet induce a realignment of the ascending proprioceptive chains, and thus a re-equilibration of the skeletal muscular system.
This concept has previously been verified by the design of the following types of soles:
soles with micro-reliefs located at the level of the reflex zones of the foot have been used for several years. However, the routine use of this type of sole is hampered by the fact that the micro-reliefs have to be very meticulously adjusted for each patient, and their precise thickness must be regularly modified. In addition, they are only active when the patient is in a standing position. PA1 soles incorporating a polarizing substance, such as a polarizing or polarizer plate have been described in U.S. Pat. No. 5,158,526. These soles have been marketed in Europe for several years and have been used for the correction of statural disorders. However, they exhibit some major drawbacks, that limit their routine clinical use. Namely, they need to be applied continuously directly at the contact of the skin of the foot sole, their efficacy being almost completely abolished when fabrics such as nylon or stained cotton, found in socks or stockings, are placed between the device and the skin. This continuous application induces increased perspiration in most of the patients, which makes them uncomfortable to wear, resulting in a poor patient's compliance. In addition, the lifetime of the active principles of these soles (superposed polarizer plates) is limited to several months, requiring a regular monitoring of the device's efficacy. PA1 a similar kind of soles incorporating at least one flexible filtering film with a determined spectral transmission curve have been described in Canadian patent No. 1,328,734. PA1 elements in crystal or powder forms, such as diamond (C), gold (Au), copper (Cu), platinum (Pt), sulfur (S or S.sub.8), silver (Ag), or bismuth (Bi); PA1 natural and synthetic sulphides and sulphosalts in the form of crystals or powders, such as argentite (AgS), arsenopyrite (FeAsS), arsenic trisulfide (As.sub.2 S.sub.3), proustite (Ag.sub.3 AsS.sub.3), pyrite (FeS.sub.2); PA1 natural and synthetic halides in the form of crystal or powders, such as fluorite (CaF.sub.2) or cryolite (Na.sub.3 AlF.sub.6); PA1 natural and synthetic oxides and hydroxides in the form of crystals or powders, such as silicon dioxide (SiO.sub.2) derivatives (quartz, jasper, topaz safranite, cornelian, aventurine, amethyst, chalcedony, agate, crystobalite, flint, sand, tridymite) or rutile (TiO.sub.2); PA1 natural and synthetic nitrates, carbonates and borates in the form of crystals or powders, such as malachite (Cu.sub.2 [(OH).sub.2 CO.sub.3 ]), azurite (Cu.sub.3 [OH/CO.sub.3 ]), cerusite (PbCO.sub.3); PA1 natural and synthetic sulfates, chromates, molybdates and tungstates in the form of crystals or powders, such as crocoite (PbCrO.sub.4) or anglesite (PbSO.sub.4); PA1 natural and synthetic phosphates, arseniates and vanadates in the form of crystals or powders, such as apatite (Ca.sub.5 [F(PO.sub.4).sub.3 ]); PA1 natural and synthetic silicates in the form of crystals or powders, such as Feldspars (AlSi.sub.3 O.sub.8 and AlSi.sub.2 O.sub.6 derivatives), micas (AlSi.sub.3 O.sub.10 and Si.sub.4 O.sub.10 derivatives); PA1 natural and synthetic organic substances in the form of crystals or powders, such as amber (C.sub.10 H.sub.16 O) or aurin (C.sub.19 H.sub.14 O.sub.3). PA1 a rapid re-equilibration of the spine towards normalization of spine curvatures and intervertebral angles, which can be clinically evidenced by disappearance of imbalances, tilts and rotations of the pelvic and scapular girdles. PA1 the relief of symptoms associated with spine disequilibrium, including chronic back and neck pains, other muscular and articular pains, vertigos, lumbagos, arthrosis. PA1 the prevention of the occurrence of the aforementioned disorders associated with spine disequilibrium. PA1 an energetic action, including an increase of physical performances and a diminution of the stress level.
Although several case reports have described the efficacy of the aforementioned types of soles, there exist no data from controlled clinical studies performed to establish their clinical usefulness. Despite the fact that anecdotal research, such as case reports, may provide some valuable information on the activity of a product, it is widely recognized by the scientific and medical communities that only placebo-controlled, double blind studies can help to fully objectively assess the efficacy and the safety of such a medical device, especially when the parameters used to measure efficacy are essentially clinical, qualitative or semi-quantitative parameters.
There is described a sole of superposed polarizing plates in U.S. Pat. No. 5,158,526 (in the name of Bricot). Bricot teaches a method and an apparatus for treating reflex zones of feet by applying polarized magnetic flux to the reflex zones of feet. Although, Bricot teaches that microcrystals may be used in his sole, he also teaches the absolute necessity to process said microcrystals into a polarizer under specific conditions such that the crystals are oriented. This polarizer is used to treat reflex zones of the feet.
Therefore, it is an object of the present invention to provide a pedal device without the use of any polarizer, such as a sole, a shoe or another pedal apparatus, that would allow to rapidly correct spine disequilibrium, and thus alleviate associated physical disorders, such as chronic back or neck pains.
It is another object of the invention to provide a type of sole that could exert a therapeutic effect when worn under socks or stockings, in order to prevent patient's discomfort, and therefore improve compliance.
It is also an object of the invention to provide a type of sole, of which the active principles would have a long lifetime, in order to avoid the need for frequent monitoring of the quality of the sole.
It is also an object of the invention to provide a type of sole with a clinical efficacy proven by data resulting from placebo-controlled, double-blind studies.